33. The representative of India said that the paper presented by the delegation of Peru responded to the view of some Members that national experiences could help them in working towards an outcome on the issue of disclosure. He said that further substantive discussions on the issue of disclosure were necessary. The Peruvian experience of establishing the National Anti-Biopiracy Commission showed that national efforts were not enough to prevent biopiracy and that an international mandatory obligation to introduce disclosure requirements in patent applications was necessary. He supported the statement made by Brazil, in its presentation of document IP/C/W/442 co-sponsored also by India, confirming the existence of biopiracy and looked forward to the views of Members on the contents of the submission.
34. Introducing document IP/C/W/443 on behalf of Brazil and India, he recalled that the United States had submitted document IP/C/W/434 during the last TRIPS Council meeting in which it had said that it viewed with utmost caution any proposals that would add uncertainties to patent rights, or undermine the role of the delicately balanced patent system. He said that the disclosure requirements in the joint proposal by India and other Members had, on the other hand, introduced certainty for researchers and bio-prospectors. It would ensure the legitimacy of the patent system and preserve and strengthen its balance. Document IP/C/W/434 had argued that new patent disclosure requirements would not work to guarantee that prior informed consent was obtained, and suggested an approach based on national level contractual arrangements. The co-sponsors of IP/C/W/443 were in agreement with the United States that national level laws were an important component in order to address the relevant goals, but have said that these were not enough. Just as national level patent regimes alone did not suffice and TRIPS Agreement had been introduced in the WTO to address that insufficiency, national level contractual arrangements could only suffice if they were obligatory and enforceable across borders.
35. He said that there was a significant international dimension of mutual supportiveness of the CBD and the TRIPS Agreement. On the one hand, Article 5 of the CBD envisaged international cooperation with competent international organizations. On the other hand, the WTO was competent with regard to international minimum standards for patents based on biological resources and/or traditional knowledge and thus, with regard to cross-border biopiracy and misappropriation. It was argued in IP/C/W/434 that the act of patenting per se did not constitute misappropriation. The co-sponsors of document IP/C/W/443 agreed and had said that what constituted a misappropriation was the act of applying for a patent or patenting an invention using biological resources and/or traditional knowledge without obtaining prior informal consent and sharing benefits. The disclosure proposal remedied such form of misappropriation. The document had also argued that the disclosure requirement per se could not transfer benefits, since it would merely convey the information required but would have no mechanism to transfer benefits. However, the proposed disclosure of the use of biological material or traditional knowledge and evidence of prior informed consent and benefit-sharing arrangements, coupled with the national level regimes on prior informed consent and ABS would ensure the transfer of benefits.
36. Further, IP/C/W/434 argued that benefits from an invention would be diminished if patents were not issued, or revoked, and yet inventions were commercialized. However, this phenomenon was not limited to patents related to biological material and could happen to any invention. As in any other case, other legal means would have to be used to rectify the damage, such as parallel importation
37. He said that the submission from the United States had argued that the disclosure requirements would be ineffective in preventing erroneously granted patents, and did little to ascertain inventorship, novelty or inventive step. However, the disclosure requirement would ensure that information is disclosed on whether biological resources and/or traditional knowledge had been used; (a) to form part of the claimed invention, (b) in developing the invention, (c) as its necessary pre-requisite, (d) in facilitating the invention, or (e) as its necessary background material or information. Such information would be relevant in determining prior art, non-obviousness and inventorship or entitlement to a patent. IP/C/W/434 accepted this premise when it refers to the benefits of organized searchable databases.
38. He recalled that document IP/C/W/434 had raised concerns on administrative burdens and costs and on the capacity of patent examiners to determine the validity of prior informed consent or adequate benefit-sharing. The issue of administrative burdens and costs had been addressed in document IP/C/W/429/Rev. l. In terms of implementation for the US system, the proposed disclosure requirement would not be burdensome at all, as it could be covered under the existing requirement of information material to patentability. What would need to be included was evidence of prior informed consent and benefit-sharing arrangements. The proposal did not require patent examiners to determine the validity of these arrangements in order to grant a patent.
39. Furthermore, IP/C/W/434 had proposed an alternative mechanism outside the patent system. But a fragmented nation-to-nation system would not achieve the objectives and would imply high transaction costs. National-level requirements could do little to address the transnational character of biopiracy. Organized searchable databases were useful to determine prior art but were complementary to and could not substitute for the disclosure requirement. He said that the explanations contained in the paper presented by his delegation should persuade all Members of the benefits of the disclosure requirement and the conclusion that there was no further alternative.
40. Speaking on behalf of India, he referred to the earlier papers that had been co-sponsored by his delegation, and said that they sought to address the mandate contained in paragraph 12 and 19 of the Doha Ministerial Declaration and the realization of a key development dimension, guided by the principles and objectives of the TRIPS Agreement as set out in Articles 7 and 8, and responded to the need for an outcome as part of the conclusion of the work programme set out in the Doha Ministerial Declaration.
